The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Copalis Rubella Igm.
Device ID | K993291 |
510k Number | K993291 |
Device Name: | COPALIS RUBELLA IGM |
Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
Applicant | DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
Contact | Judith J Smith |
Correspondent | Judith J Smith DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
Product Code | LFX |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-01 |
Decision Date | 2000-02-10 |
Summary: | summary |